U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. DDT COA #000119: PROMIS® Pediatric Chronic Kidney Disease Short Form- Sleep Disturbance
  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000119: PROMIS® Pediatric Chronic Kidney Disease Short Form- Sleep Disturbance

Clinical Outcome Assessments (COA) Qualification Submissions
Office of cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Cardiovascular and Nephrology (DCN)

DDT COA Number
DDT COA #000119

Instrument Name
PROMIS® Pediatric Chronic Kidney Disease Short Form- Sleep Disturbance

Disease/Condition
Chronic Kidney Disease (CKD)

Concept of Interest
Sleep Disturbance

Context of Use
Children (8-17 years) with CKD

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted

Requestor(s)
Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium

Contact(s)
Carole Tucker
Christopher Forrest

Date Accepted into CDER’s COA Qualification Program
January 15, 2020

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 10/11/19 FDA Response (Accepted) 1/11/20
Back to Top